💬In plain words
What the trial is, and whether it could suit you
Transjugular intrahepatic portosystemic shunt (TIPS) is a key therapeutic intervention for complications of portal hypertension. However, the risk of post-procedural hepatic encephalopathy (HE) limits its broader clinical application. In the management of gastroesophageal variceal bleeding, the primary goal of TIPS is to reduce the portosystemic pressure gradient (PPG) to less than 12 mmHg (16 cmH₂O), which defines the standard TIPS procedure. The investigators hypothesize that, in patients undergoing TIPS for the prevention of variceal rebleeding, stent underdilation using a 6-mm balloon (underdilated TIPS) will not increase the risk of rebleeding but may reduce the incidence of overt HE and attenuate liver injury. To test this hypothesis, the investigators have designed a prospective, multicenter, randomized controlled trial.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1\. Age 18-75 years. 2. Diagnosis of liver cirrhosis according to the 2023 Consensus Opinion on the Clinical Diagnosis and Treatment of Liver Cirrhosis in China (Chinese Society of Gastroenterology). Diagnosis is based on clinical manifestations and imaging findings; histological confirmation is required if the diagnosis remains inconclusive.
3\. High-risk acute variceal bleeding, defined as any of the following:
1. High-risk acute esophageal or type 1 gastroesophageal variceal bleeding, including: Child-Pugh grade B with a score \> 7 and endoscopic evidence of active bleeding; Child-Pugh grade C with a score \< 14.
2. Hepatic venous pressure gradient (HVPG) \> 20 mmHg during bleeding.
3. Early rebleeding within 5 days.
4. Bleeding uncontrolled despite pharmacological and endoscopic therapy. 4. History of esophageal or gastric variceal bleeding with failure of standard first-line treatment \[endoscopy combined with non-selective beta-blockers (NSBB)\]; or first hemorrhage accompanied by grade 2 ascites and/or portal vein thrombosis; GOV2 or IGV1 gastric variceal bleeding; ectopic variceal bleeding; or bleeding from refractory portal hypertensive gastropathy.
5\. Planned TIPS procedure. 6. Ability and willingness to provide written informed consent.
Exclusion Criteria:
1. Budd-Chiari syndrome or other causes of non-cirrhotic portal hypertension.
2. Current or prior malignancy, including hepatocellular carcinoma or malignancies of other organs.
3. Complete thrombosis of the main portal vein.
4. Severe psychiatric or neurologic disorders (e.g., uncontrolled epilepsy, dementia).
5. Prior liver resection or liver transplantation.
6. Prior TIPS or surgical portosystemic shunt.
7. Pregnancy or lactation.
8. Any contraindication to TIPS, including:
(1) Congestive heart failure (New York Heart Association class C or D, or left ventricular ejection fraction \< 50%).
(2) Severe pulmonary hypertension (mean pulmonary artery pressure \> 45 mmHg as measured invasively).
(3) Uncontrolled systemic infection. (4) Severe overt hepatic encephalopathy (OHE) with unmodifiable spontaneous portosystemic shunt.
9.Acute hemorrhage with a MELD score ≥ 30 and/or arterial lactate \> 12 mmol/L, or presence of acute-on-chronic liver failure (ACLF).
10\. Systemic conditions requiring ongoing glucocorticoid or nonsteroidal anti-inflammatory drug (NSAID) therapy.
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